Endoscopic Sleeve Gastroplasty Clinical Trial
Official title:
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition. 1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy. 1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 16, 2026 |
Est. primary completion date | December 16, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Patients>18 years of age undergoing endoscopy for any of the following indications: Indications for Tissue Apposition: - Closure of perforations - Closure of full thickness defects created during endoscopic full thickness resection - Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection - Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM) - Stent fixation - Closure of fistulas - Natural Orifice Transluminal Endoscopic Surgery defect closures - Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair) - Primary endoscopic sleeve gastroplasty Exclusion Criteria: - Patients unable or unwilling to provide consent - Pregnant patients - Coagulation disorders (INR >1.8, platelet <50,000) - GI Bleeding - Hemodynamic instability - Enrollment in another device or drug study that may confound the results |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical and clinical success in endoscopic tissue apposition | Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed.. | From baseline to one year | |
Primary | Adverse Events | Based on ASGE criteria | From baseline to one year |
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